METHOCEL™ E4M Premium CR HPMC

1 of 30 products in this brand
METHOCEL™ E4M Premium CR HPMC is water-soluble and used in suspensions, granulation, and tablet coating. It serves as a binder, controlled release agent, film former, gelling agent, and immediate release agent in pharmaceuticals and nutraceuticals, and as a binder in ceramics.

Chemical Name: Hydroxypropyl Methylcellulose

CAS Number: 9004-65-3

Dosage Form: Suspension

Labeling Claims: APE-free, Aflatoxin-free, Aluminum-free, Antibiotics-free, BSE-free, Bisphenol A-free, Caffeine Free, Colorants-free, Dioxin-free, Dye Free, Endocrine Disruptor-free, Glycerin-free, Halal, Hormones-free, Hypoallergenic, Kosher, Low Odor, Monosodium Glutamate (MSG)-free, Mycotoxins-free, Natural Latex Rubber-Free, Naturally Derived, Not Listed In California Proposition 65, Odor-free, PAH-free, PFAS-Free, PFOS-free, PHO (Partially Hydrogenated Oil)-Free, PVC-free, Palm Oil-free, Paraben-free, Pareve, Perfluorooctanoic Acid-free, Pesticide-free, Phthalates-free, Plant-Based, Plasticizer-free, Preservative-free, Sugar-free, TSE-free, Tributyl Tin Compounds-Free, Triphenyl Tin Compounds-Free, USP 232 Elemental Impurities Free, Vegan, Vegetarian, Zero Calorie

Certifications & Compliance: British Pharmacopeia (BP), CFDA Compliant (China), Chinese Pharmacopeia (ChP), Doping-Free, EXCiPACT, European Pharmacopeia (Ph. Eur.), European Regulation 396/2005/EC, FCC Compliant, FDA 21 CFR 172.874, FDA 21 CFR 182.1480, FDA Compliant, FDA Food Safety Modernization Act (FSMA), GMP, Generally Recognized As Safe (GRAS), Halal, ICH Q3C, ISO 14001, Japan Pharmacopeia (JP), National Formulary (NF), Regulation (EU) No. 10/2011 (PIM), Regulation (EU) No. 1272/2008, Regulation (EU) No. 231/2012, United States Pharmacopeia (USP)

Manufacturing Technology: Granulation, Tablet Coating

Synonyms: Hydroxypropyl methyl cellulose ether, Methyl hydroxypropyl cellulose, Cellulose hydroxypropyl methyl ether, 2-Hydroxypropyl methyl cellulose, 2-Hydroxypropyl methyl cellulose ether, Hydroxypropyl methyl cellulose, HPMC, Hypermellose, Hypromellose

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Enhanced TDS

Identification & Functionality

Chemical Family
Cellulose & Cellulosics,
Cellulose Ethers
Chemical Name
Hydroxypropyl Methylcellulose
Ingredient Origin
Plant Origin
Pharma & Nutraceuticals Functions
Binder,
Controlled Release Agent,
Film Former,
Gelling Agent,
Immediate Release Agent,
Mucoadhesive,
Solubilizer,
Sustained Release Agent,
Thickener,
Viscosity Modifier
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Emulsifiers & Stabilizers,
Formulation & Processing Aids,
Modified & Controlled Release,
Pharmaceutical Coatings,
Solvents & Solubilizers

Features & Benefits

Labeling Claims
APE-free,
Aflatoxin-free,
Aluminum-free,
Antibiotics-free,
BSE-free,
Bisphenol A-free,
Caffeine Free,
Colorants-free,
Dioxin-free,
Dye Free,
Endocrine Disruptor-free,
Glycerin-free,
Halal,
Hormones-free,
Hypoallergenic,
Kosher,
Low Odor,
Monosodium Glutamate (MSG)-free,
Mycotoxins-free,
Natural Latex Rubber-Free,
Naturally Derived,
Not Listed In California Proposition 65,
Odor-free,
PAH-free,
PFAS-Free,
PFOS-free,
PHO (Partially Hydrogenated Oil)-Free,
PVC-free,
Palm Oil-free,
Paraben-free,
Pareve,
Perfluorooctanoic Acid-free,
Pesticide-free,
Phthalates-free,
Plant-Based,
Plasticizer-free,
Preservative-free,
Sugar-free,
TSE-free,
Tributyl Tin Compounds-Free,
Triphenyl Tin Compounds-Free,
USP 232 Elemental Impurities Free,
Vegan,
Vegetarian,
Zero Calorie

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Segments
Dietary Supplement,
Pharmaceutical
Applications
Dietary Supplement — Controlled release
Pharmaceutical — Controlled release
Dosage Form
Suspension
Manufacturing Technology
Granulation,
Tablet Coating

Properties

Physical Form
Powder
Soluble In
Water Soluble
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 2% solution)*5.0 - 8.0-USP/EP/JP/CHP
Microbiological Values
ValueUnitsTest Method / Conditions
E. coli*Absent/gCurrent USP Negative
Pseudomonas aeruginosa*Absent/1gCurrent USP Negative
Salmonella*Absent/10gCurrent USP Negative
Staphylococcus aureus*Absent/gCurrent USP Negative
Yeast and Mold Count*max. 100/gCurrent USP Combined Mold And Yeast
Total Plate Count*max. 100/gCurrent USP Total Aerobic
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content*7.0 - 12.0%USP/EP/JP/CHP
Methoxyl Content*28.0 - 30.0%USP/EP/JP/CHP
Specifications
ValueUnitsTest Method / Conditions
Opalescence*Pass-Current EP Opalescence
Color Evaluation*Pass-Current EP Solution Color
Identification*Pass-USP/EP/JP/CHP
Residual Solvent*Pass-Current USP/EP/JP
Sulfated Ash Content*max. 1.5%Current USP/EP/JP
Loss on Drying*max. 5.0%USP/EP/JP/CHP
Residue on Ignition*max. 1.5%USP/JP/CHP
Apparent Viscosity (at 20°C, 2% in water)*2,663 - 4,970mPa.sUSP/EP/JP/CHP
Apparent Viscosity (Target)*3550mPa.s-
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals (as Lead)*max. 10mg/KgUSP/EP/JP/CHP
Magnetic Iron Content*max. 5mg/KgPSM 100041
Magnetic Iron Content (Target)*0mg/Kg-
Screen Test
ValueUnitsTest Method / Conditions
Screen (< 149 micron, through 100 U.S. STD.Sieve)*min. 95.0%PSM 100669
Screen (< 420 micron, through 40 U. S. STD. Sieve)*min. 99.0%PSM 100669
Note

*PHS - All section names come under PHS
[AB] = Audit Basis

Regulatory & Compliance

Certifications & Compliance
British Pharmacopeia (BP),
CFDA Compliant (China),
Chinese Pharmacopeia (ChP),
Doping-Free,
EXCiPACT,
European Pharmacopeia (Ph. Eur.),
European Regulation 396/2005/EC,
FCC Compliant,
FDA 21 CFR 172.874,
FDA 21 CFR 182.1480,
FDA Compliant,
FDA Food Safety Modernization Act (FSMA),
GMP,
Generally Recognized As Safe (GRAS),
Halal,
ICH Q3C,
ISO 14001,
Japan Pharmacopeia (JP),
National Formulary (NF),
Regulation (EU) No. 10/2011 (PIM),
Regulation (EU) No. 1272/2008,
Regulation (EU) No. 231/2012,
United States Pharmacopeia (USP)
Chemical Inventories
AICS (Australia),
DSL (Canada),
ENCS (Japan),
IECSC (China),
KECI (Korea),
NDSL (Canada),
PICCS (Phillipines),
TSCA (USA)
Quality Standards
EN ISO 9001:2015,
GMP,
ICH Q3D

Technical Details & Test Data

Nutritional Information
USA
Nutritional Information (per 100 g)
Carbohydrates (g) 0
Non-Digestible Carbohydrates (g) 93.5
Water (g) 5
Ash (g) (includes salt and iron) 1.5
Total Fat (g) 0
Saturated Fat (g) 0
Trans Fat (g) 0
Protein (g) 0

 

Additional Nutrient Information (per 100 g)
Calories (Energy) (kcal) 0
Cholesterol (mg) 0
Total Dietary Fiber (g) 0
Soluble Fiber (g) 93.5
Insoluble Fiber (g) 0
Sugars (g) 0
Added Sugars (g) 0
Sodium (mg) 390
Chloride (mg) 610
Potassium (mg) 0
Magnesium (mg) 0
Iron (mg) 15
Zinc (mg) 0
Total Vitamin A (IU) 0
Vitamin C (mg) 0
Thiamin (mg) 0
Riboflavin (mg) 0
Vitamin D (IU) 0
Niacin (mg) 0
Vitamin B6 (mg) 0
Calcium (mg) 0
Phosphorus (mg) 0

 

European Union
Nutritional Information (per 100 g)
Energy

748 kJ / 187 kcal
Fat 0 g
Of which saturates 0 g
Carbohydrates 0 g
Of which sugars 0 g
Fibre 93.5 g
Protein 0 g
Salt 1.5 g

 

Australia & New Zealand
Nutritional Information (per 100 g)
Energy (kJ) 748
Carbohydrates (g) 0
Dietary Fibre (g) 93.5
Water (g) 5
Ash (g) (includes salt and iron) 0.4
Total Fat (g) 0
Saturated Fat (g) 0
Trans Fat (g) 0
Protein (g) 0

Packaging & Availability

Packaging Type
Bags,
Boxes,
Drums,
Super Sacks